CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report
S4C Occiput Torque Wrench F/Set Screw recalled by Aesculap
Aesculap is recalling S4C Occiput Torque Wrench F/Set Screw, distributed nationwide in the US. The recall was initiated on 7 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2326-2015
- FDA event ID
- 71709
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2015
- FDA classified
- 3 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 7 Jul 2015 | Recall initiated by company | |
| 3 Aug 2015 | Classified by FDA | +27 days |
| 12 Aug 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
Where it was distributed
Distributed US (nationwide) and to Canada.
Questions about this recall
Is S4C Occiput Torque Wrench F/Set Screw recalled?
Yes. Aesculap recalled S4C Occiput Torque Wrench F/Set Screw on 7 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2326-2015.
Why was it recalled?
A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
Which lots are affected?
product: FW103R, all Lots
Where was it sold?
Distributed US (nationwide) and to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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